# Urothealth System, Inc.

- Location (FDA's records): Richland, MI
- FDA decisions: 1 (1998–1998): 1 510(k) clearance
- Product codes: KNW (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Imagyn Surgical: 1 (https://510kreport.com/company/imagyn-surgical)

## Its most-cited devices
- K972328: Percutaneous Breast Biopsy (PBB) (1998), cited by 1

## Recent decisions
- K972328: Percutaneous Breast Biopsy (PBB) (Jul 7, 1998)

Source page: https://510kreport.com/company/urothealth-system